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The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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Novo Nordisk on Monday reported the oral version of its drug semaglutide reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes by 14% in a large Phase III trial.
Sanofi will sell a 50% controlling stake in consumer healthcare unit Opella to private equity firm CD&R, with the French government taking a stake as well to ensure the business remains in the county.
FDA
In a short statement Friday, Lykos Therapeutics expressed optimism about a recent meeting with the regulator to discuss next steps for the embattled program, following the FDA’s rejection in August 2024.
BMO Capital Markets analyst Evan Seigerman in a note to investors said the late-stage data for Vertex’s experimental non-opioid pain medication “reaffirms our confidence in the strength of suzetrigine’s profile.” However, William Blair analysts view these data as “an incremental positive” as the company faces challenges in targeting the acute pain market.
With Friday’s ruling by New Jersey District Judge Zahid Quraishi, Novartis joins a growing list of pharmaceutical companies that have failed in their legal challenges to the Inflation Reduction Act.
The regulator’s approval on Friday of Vyloy for gastric or gastroesophageal junction cancer makes it the first and only claudin 18.2–targeted therapy approved in the U.S. for these indications, according to Astellas.
United States Pharmacopeia is recruiting expert volunteers from academia, industry, regulatory and healthcare to develop, revise and approve medicine, dietary supplement and food ingredient standards and solutions used in more than 150 countries to improve global public health. The volunteers will serve from 2025 to 2030.
Pharmaceutical companies are combining antibodies with radioisotopes in a bid to more precisely deliver radiation to cancers and tumors.
Massachusetts residents voted Tuesday against the Natural Psychedelic Substances Act, which would have seen some psychedelics, including psilocybin and dimethyltryptamine, legalized in the state.
In the wake of Pfizer’s voluntary market withdrawal of the popular sickle cell disease therapy, BioSpace looks at five investigational drugs currently making their way through the pipeline.